Boston Scientific gains FDA sign-off for 3 new pacemakers

Ingenio pacemaker--courtesy of Boston Scientific

Boston Scientific ($BSX) is touting a slew of new FDA approvals. Regulators signed off on the Natick, MA-based company's Ingenio and Advantio pacemakers, as well as its Invive cardiac resynchronization therapy pacemakers.

The approvals and subsequent market launches come about a month after the company gained CE marks for the three products and began selling them commercially in Europe. Investors liked the news, and Boston Scientific's stock rose moderately in early trading, a 1.5% jump to $6.28.

Certainly, there are plenty of pacemakers in the marketplace, particularly from rivals Medtronic ($MDT) and St. Jude Medical ($STJ), in addition to others offered by Boston Scientific. But Boston Scientific bills these products as standing out, in part because of new bells and whistles. For example, the Ingenio and Advantio are built with technology designed to treat chronotropic incompetence, or the inability of the heart to regulate its rate in response to physical activity. And Ingenio and Invive offer technology designed to monitor respiration.

In a crowded marketplace, the company sees the trio of devices as having even more relevance in how physicians monitor the data. The Ingenio, Advantio and Invive devices are supposed to be used with Boston Scientific's Latitude NXT remote patient monitoring system, according to the company. FDA officials are reviewing the product, which would allow physician access to patient pacemaker and heart data through a secure website or an AT&T cell phone.

The new products, including some updated defibrillators approved late last fall, will have plenty of pressure to perform. Boston Scientific's cardiac rhythm management unit generated $501 million in sales in the first quarter, down from $559 million a year earlier.

- here's the release